CMC Regulatory Director - Global Strategy & Submissions
$177k - $278.08kJobRx, Inc.
JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position offers a hybrid work model and a competitive salary ranging from $177,000 to $278,080, alongside comprehensive benefits including health insurance, 401(k) plan, and paid time off. #J-18808-Ljbffr JobRx, Inc.
- ...pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and... ...The candidate will prepare regulatory submissions, interact with health authorities like... ...role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema...Suggested
$142.5k - $256.5k
...The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory... ...developing global regulatory CMC strategies and collaborating with key stakeholders... ...regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify...SuggestedPermanent employmentWork at officeWork from home- Noema Pharma is seeking a Director of Regulatory Affairs to lead the development and commercialization of products in clinical programs. This... ...pharmaceutical industry. The Director will develop regulatory strategies, interact with health authorities such as the FDA, and...SuggestedLocal area
- ...Inc. is seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing &... ...successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must hold a...Suggested
$177k - $278.08k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...develops the regulatory CMC strategy and leads the execution of regulatory... ...of global registrational submissions of complex drug product or suite...SuggestedMinimum wageTemporary workLocal areaImmediate startRemote workWorldwide$137k - $215.27k
...This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...registration and/or post-approval strategies for assigned products. RA... ...development of robust and accurate submissions. Develops constructive...Minimum wageFull timeTemporary workLocal areaImmediate startRemote workWorldwide$177k - $278.08k
.... This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...develops the regulatory CMC strategy and leads the execution of regulatory... ...of global registrational submissions of complex drug product or...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...How you will contribute: Leads and develops a team of regulatory leaders and subject matter experts; oversees global CMC regulatory strategy and key submissions/health authority interactions for a portfolio of small molecule and biologic products through Phase 2. Partners...
$238k - $374k
...patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination... ...innovative and robust regulatory strategies for medical devices and drug-device... ...regulatory strategy and major submissions for an assigned portfolio of medical...Minimum wageTemporary workWork at officeLocal areaRemote workWorldwide$177k - $278.08k
...changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and... ...functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- Moderna Therapeutics in Norwood, MA is seeking a Regulatory CMC Lead to manage a team of CMC experts. This role involves overseeing regulatory strategies for a portfolio of products, ensuring compliance with health authority guidelines, and leading interactions with regulators...
$137k - $215.27k
...for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device... .... Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a...- Initial Therapeutics, Inc. is seeking a seasoned regulatory leader to develop and execute global regulatory strategy for its oncology portfolio. The role requires... ...Key responsibilities include leading regulatory submissions and health authority interactions, anticipating...
- ...Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This... ...developing and executing regulatory strategies to support global product development, particularly... ...the ability to manage regulatory submissions and work with health authorities such...
$196.7k - $353.4k
...seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will... ...development through commercialization Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgency Lead...Permanent employment- Page Mechanical Group, Inc. is looking for an Executive Director of Regulatory Operations and Submission Management. This strategic role oversees the global regulatory processes ensuring high-quality submissions and compliance across the product lifecycle. The ideal candidate...
$187.5k - $275k
...Senior Director Regulatory Strategy page is loaded## Senior Director Regulatory Strategylocations... ...around the world. We are a global healthcare leader... ...regulatory strategy, submissions, and compliance activities... ...clinical, nonclinical, and CMC regulatory strategy including...Full timeWork at officeFlexible hours3 days per week$211.85k - $317.78k
...Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately...Hourly payTemporary workWork at office3 days per week$172k - $236.5k
...part of their core business strategies, and has been named four times... ...R&D, Clinical Development, Regulatory, CMC, Finance, Commercial,... ...initiatives with the Head of Global Initiatives and SVP, Global... ...other than candidates. The submission of unsolicited resumes by recruitment...Full time- ...biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves... ...activities, ensuring compliance with global regulations, and leading efforts to... ...external partners while driving innovative regulatory strategies. #J-18808-Ljbffr Takeda
- Takeda in Boston is looking for a GRA CMC Product Lead to oversee regulatory CMC strategies and lead submissions for investigational, registration, and post-approval processes. This role requires a strong background in biopharmaceuticals with 10+ years in the industry...
- How you will contribute: Lead and develop a team of regulatory leaders and subject matter experts; oversee global regulatory strategy and major submissions for a portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution...
- ...biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory... ...Affairs experience, particularly with CMC requirements for Small Molecule drugs....Work at office
- ...leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic... ..., ensuring compliance, and overseeing global regulatory strategies. The ideal candidate will have over 15 years of...
- A leading BioPharmaceutical company seeks a Senior Director, Global Regulatory Strategy, to lead regulatory efforts for early-stage products and ensure alignment with health authority expectations. The role demands extensive regulatory experience in the pharmaceutical...
$142.5k - $256.5k
Overview The Associate Director, Global Regulatory, CMC will coordinate regulatory CMC activities for one... ...developing global regulatory CMC strategies and guiding product teams, with responsibility... ...regulatory strategies for global submissions (e.g., IND/CTA/BLA/MAA) and...$160k - $196k
...Associate Director, Regulatory Operations Global Submission Management page is loaded## Associate Director, Regulatory... ...we are strengthening our workforce strategy to ensure we have the right talent... ...including Regulatory Strategy, CMC, Clinical, Labeling, and vendors to...Minimum wageFull timeLocal areaRemote workFlexible hours- AstraZeneca is hiring a Senior Director, Biostatistics in Boston,... ...This role involves leading a global team of statisticians,... ...interpretation of clinical programs and regulatory submissions. The ideal candidate will develop biostatistics strategies for drug development and...
- Allergan is seeking a Senior Director Regulatory Affairs Therapeutic Area Head in Cambridge, MA. This leadership role involves managing global regulatory strategies and supervising a team of global regulatory leads. Applicants should have over 10 years of experience in...
- ...experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts... ...and executing regulatory strategies that support global product... ...is preferred. CMC experience is a plus. Responsibilities... ...Lead the preparation, submission, and maintenance of...
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